In the position of a QA Senior Specialist, you will be reporting directly to the QA Operations Manager and your duties will include:
- Managing investigation reports and CAPAs, ensuring accurate, complete, logical, and well-documented investigations whilst verifying that the scope of the investigation and root cause analysis are adequate.
- Ensuring that state of the art root cause analyses are performed and that the documentation of these actions are GMP compliant;
- Coordinating the overall CAPA management by providing guidance to other departments during investigations, working closely with customers, CAPAs implementation and monitoring applications in liaison with QA managers;
- Approving DR and CAPA on behalf of the QP;
- Participating in customer and Regulatory audits from a CAPA management system standpoint.
Education and Experience
- A Bachelor’s degree in Life Science or a related discipline
- Previous experience in CAPA management within a pharmaceutical industry environment
- Experience in Root Cause Analysis, investigations, technical / report writing, and extensive knowledge of quality systems
- Strong communication skills
- Attention to detail and ability to lead
- Effective time management and prioritization skills
- Fluency in written and spoken Maltese and English
This position is with an international pharmaceutical company in Malta.
Job reference code: CU737